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Nitric Oxide Releasing Solution
Nitric Oxide Releasing Solution is a Small molecule drug developed by Sanotize Research and Development corp.. It is currently in Phase 2 development. Also known as: Nitric Oxide Nasal Spray.
Nitric Oxide Releasing Solution is being studied as a treatment for various conditions, including Diabetic Foot Ulcer, Verruca Plantaris, SARS-CoV Infection, Candidiasis, and Alopecia Androgenica. It is delivered as an adjunctive footbath treatment, with one study comparing its safety and efficacy to a placebo in the treatment of Diabetic Foot Ulcer.
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Baseline phase 2 → approval rate
+15.3pp
Industry-wide phase 2 drugs reach approval ~15.3% of the time (BIO/Informa 2023 industry benchmark across all therapeutic areas).
| Regulator | Country | Likely year | Lag vs FDA |
|---|---|---|---|
| FDA | US | 2031–2034 | — |
| EMA | EU | 2032–2035 | +0.7 yr |
| MHRA | GB | 2032–2035 | +0.7 yr |
| Health Canada | CA | 2032–2036 | +0.9 yr |
| TGA | AU | 2032–2036 | +1.2 yr |
| PMDA | JP | 2032–2036 | +1.5 yr |
| NMPA | CN | 2033–2037 | +2.3 yr |
| MFDS | KR | 2032–2036 | +1.4 yr |
| CDSCO | IN | 2032–2037 | +1.8 yr |
| ANVISA | BR | 2033–2037 | +2.3 yr |
Hover any row for the lag rationale. Lag estimates are reduced when the drug has FDA Breakthrough or EMA PRIME designation (sponsors file globally in parallel).
Estimate based on the BIO/Informa industry phase transition rates plus per-drug modifiers for therapeutic area, sponsor type, FDA designations, mechanism, and trial design. Per-jurisdiction lags from Tufts CSDD international approval studies. Not investment, clinical or regulatory advice. Methodology: /methodology#likelihood.
At a glance
| Generic name | Nitric Oxide Releasing Solution |
|---|---|
| Also known as | Nitric Oxide Nasal Spray |
| Sponsor | Sanotize Research and Development corp. |
| Modality | Small molecule |
| Phase | Phase 2 |
Approved indications
Common side effects
Key clinical trials
- Safety and Tolerability of TOP-N53 Applied on Digital Ulcers in Patients With Systemic Sclerosis (PHASE2)
- Nitric Oxide Nasal Spray (NONS) as Prevention for Treatment of Individuals at Risk of Exposure to COVID-19 Infection (PHASE3)
- Evaluation of Nitric Oxide Nasal Spray (NONS) for Treatment of Recurrent Acute Rhinosinusitis (PHASE2)
- Nitric Oxide Releasing Mouthwash (NORM) for the Management of Oropharyngeal Candidiasis (PHASE1)
- Nitric Oxide Releasing Solution (NORS) For The Treatment Of Human Papillomavirus(HPV) Verrucae Plantaris (Plantar Warts) (PHASE2)
- Nitric Oxide Footbath for Treatment of Diabetic Foot Ulcers (PHASE1, PHASE2)
- Nitric Oxide Nasal Spray (NONS) To Treat and Prevent the Exacerbation of Infection in Individuals With Mild COVID-19 (PHASE3)
- Nitric Oxide Releasing Sinus Irrigation (NOSi) to Treat Recalcitrant Chronic Rhinosinusitis (RCRS) (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- Nitric Oxide Releasing Solution CI brief — competitive landscape report
- Nitric Oxide Releasing Solution updates RSS · CI watch RSS
- Sanotize Research and Development corp. portfolio CI
Frequently asked questions about Nitric Oxide Releasing Solution
What is Nitric Oxide Releasing Solution?
Who makes Nitric Oxide Releasing Solution?
Is Nitric Oxide Releasing Solution also known as anything else?
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Related
- Manufacturer: Sanotize Research and Development corp. — full pipeline
- Also known as: Nitric Oxide Nasal Spray
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing